- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05392257
Efficacy and Safety of Rituximab Plus Zanubrutinib and Lenalidomide for Relapsed and Refractory Diffuse Large B Cell Lymphoma, a Multicenter, Open and Prospective Clinical Trial
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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Shandong
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Qingdao, Shandong, 중국, 266042
- 모병
- Qingdao Central Hospital
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연락하다:
- Ling Wang, MD
- 전화번호: 053268665401
- 이메일: wldoctor@126.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:1.Volunteer for clinical research; fully understand the study and sign an informed consent (ICF); be willing to follow and be able to complete all study steps; 2.Histologically confirmed diffuse large B cell lymphoma (DLBCL), and CD20-positive patients; 3.Age from 18 to 80 (patients with age > 80 and status score > 2 should be assessed by the investigator to make sure whether they are suitable for this clinical trail); 4.Relapse / refractory DLBCL, relapse or refractory disease is defined as: 1) disease recurrence after complete remission (CR), 2) partial remission (PR), disease stability (SD) or disease progression (PD) after the final treatment before the study; patients who younger than 65 should be treated with at least two different chemotherapy regimens, and patients age> 65 need at least one chemotherapy regimen, or relapse after remission; 5.Patiens have measurable lesions, the standard is showed in Appendix 1; 6.ECOG score is no more than 2; 7.The expected survival period is greater than 3 months; 8.Adequate organ and bone marrow function, no severe hematopoietic dysfunction, no cardiac, lung, liver, kidney, thyroid dysfunction, or immune deficiency (no blood transfusion, granulocyte colony stimulating factor, or other medical support drugs within 7 days prior to the start of this study) : neutrophil absolute count (ANC) ≥1.0×109/L, platelet (PLT) ≥50×109/L, hemoglobin >80 g/L, aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5×ULN, total bilirubin (TBIL) ≤1.5×ULN, creatinine clearance (Ccr) ≥40ml/min (estimated by Cockcroft-Gault formula), international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) and activated partial thrombin time (APTT) ≤1.5×ULN (unless the subject is receiving anticoagulant therapy at screening time); 9.Patiens will be enrolled only after the toxicity of the previously treated return to 《the Common Terminology Criteria for Adverse Events》 (CTCAE) V 5.0 score<1. Irreversible toxicity caused by previous antitumor treatment and is not expected to worsen than grade 2 toxicity (e. g. thrombocytopenia, anemia, neurotoxicity, hair loss and hearing loss, during the study) should be evaluated by the investigator; 10.Patiens who do not meet the criteria for ASCT or who refuse ASCT. Patiens who relapse after ASCT can be enrolled at least 100 days after the transplantation.
11.Before starting treatment, two pregnancy tests (at least one of them should be a serological pregnancy test) should be performed and the result must be negative.The first test must be conducted within 10-14 days before lenalidomide treatment, and the second test should within 24 hours before lenalidomide treatment.
12.Fertile women must agree to use reliable contraception from 4 weeks before lenalidomide treatment to at least 90 days after the last administration of zanubrutinib and lenalidomide, or 12 months after the last administration of rituximab (whichever is longer as the standard). Male patients taking the study drug may not donate sperm throughout the study.
13.Patients are not allowed to donate blood during lenalidomide treatment and within 4weeks after withdrawal, as blood may be used in pregnant female patients whose fetus will not be exposed to lenalidomide.
Exclusion Criteria:1.Special type of lymphoma: primary mediastinal (thymus) large B cell lymphoma.
2.Patients with other hematological diseases and non-lymphoma were diagnosed. 3.Other active malignancies that require concurrent treatment. 4.Major surgery is performed within 4 weeks before screening. 5.Previous anticancer therapy toxicity is still equal to or more than grade 2 when enrol (except for alopecia, ANC, hemoglobin and platelet toxicity); ANC, hemoglobin and platelet-related requirements, please follow the inclusion criteria 9.
6.History of other active malignant diseases within 2 years prior to study entry, but the following situation are eligibility for inclusion: 1) adequately treated carcinoma in situ of the cervix; 2) Local basal cell carcinoma or squamous cell carcinoma of the skin; 3) Pre-existing malignant disease that has been controlled and treated locally and radically (surgically or otherwise).
7.Have clinically significant cardiovascular disease, including: 1) myocardial infarction that occurred within 6 months prior to screening stage; 2) Unstable angina pectoris within 3 months before screening stage; 3) Clinical major arrhythmia (e.g., persistent ventricular tachycardia, ventricular fibrillation, tachycardia with torsional tip); 4) QTcF (corrected according to Fridericia formula) >480 msec; 5) History of second-degree type II atrioventricular block or third-degree ATrioventricular block; 6) Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA).
8.History of severe hemorrhagic disease, such as hemophilia A, hemophilia B, von willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
9.History of stroke or intracranial hemorrhage within 6 months prior to the first taking of the investigational drug.
10.Inability to swallow capsules or a medical condition that significantly affects gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction; 11.Uncontrolled systemic infection requiring intravenous administration of drugs for parenteral anti-infective therapy.
12.Human immunodeficiency virus (HIV) infection, or presence of serological status of active hepatitis B or C virus infection: 1)Either hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive serology can be enrolled if hepatitis B virus (HBV) DNA (<20 IU/mL) and are willing to receive monthly HBV reactivation monitoring. 2) For patients in the presence of hepatitis C virus antibody, they could be enrolled if HCV RNA is not detected.
13.Hypersensitivity is known to either lenalidomide or rituximab, or to chemical or biological analogues of lenalidomide and rituximab.
14.Women during pregnancy or lactation. 15.Any life-threatening disease, medical condition, or incomplete organ system as considered by the investigator that may affect the safety of the subject or lead to the study risk.
16.History of deep venous thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months.
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Arms
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Rituximab at 375mg / m2, Day 0; Zanubrutinib 160mg bid continuously oral; Lenalidomide 25mg qd oral on days 1-21; 28 days as a course of treatment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The overall survival in this population of patients
기간: 24 months
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The overall survival of the enrolled patients from start the combination treatment of Rituximab + zanubrutinib + lenalidomide regimen
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24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The progression free survival in this population of patients
기간: 24 months
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The progression free survival of the enrolled patients from start the combination treatment of Rituximab + zanubrutinib + lenalidomide regimen
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24 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- QDCH20220521
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 지원 정보 유형
- 연구_프로토콜
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Rituximab + zanubrutinib + lenalidomide에 대한 임상 시험
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Sun Yat-sen University모병
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Johns Hopkins All Children's Hospital종료됨
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Ruijin HospitalThe First Affiliated Hospital of Nanchang University; Qilu Hospital of Shandong University 그리고 다른 협력자들모병
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Cancer Research UKBioInvent International AB; Bloodwise완전한
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Papworth Hospital NHS Foundation Trust완전한
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Centre Hospitalier Universitaire de Nice아직 모집하지 않음